MAXALT Tablet Ref.[7522] Active ingredients: Rizatriptan

Method of administration

MAXALT should not be used prophylactically.

The oral tablets should be swallowed whole with liquid.

Effect of Food

The absorption of rizatriptan is delayed by approximately 1 hour when administered together with food. Therefore, onset of effect may be delayed when rizatriptan is administered in the fed state (see also Pharmacokinetic properties, Absorption).

MAXALT is also available as an alternative oral lyophilisate.

Posology

Adults 18 years of age and older

The recommended dose is 10 mg.

Redosing: Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period.

• For headache recurrence within 24 hours: If headache returns after relief of the initial attack, one further dose may be taken. The above dosing limits should be observed.
• After non-response: The effectiveness of a second dose for treatment of the same attack, when an initial dose is ineffective, has not been examined in controlled trials. Therefore, if a patient does not respond to the first dose, a second dose should not be taken for the same attack.

Clinical studies have shown that patients who do not respond to treatment of an attack are still likely to respond to treatment for subsequent attacks.

Some patients should receive the lower (5 mg) dose of MAXALT, in particular the following patient groups:

• patients on propranolol. Administration of rizatriptan should be separated by at least two hours from administration of propranolol (see section 4.5).
• patients with mild or moderate renal insufficiency.
• patients with mild to moderate hepatic insufficiency.

Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period.

Paediatric population

Children and Adolescents (under 18 years of age)

The safety and efficacy of MAXALT in children and adolescents under 18 years of age has not yet been established.

Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.

Elderly

The safety and effectiveness of rizatriptan in patients older than 65 years have not been systematically evaluated.

Rizatriptan 40 mg (administered as either a single dose or as two doses with a two-hour interdose interval) was generally well tolerated in over 300 adult patients; dizziness and somnolence were the most common drug-related adverse effects.

In a clinical pharmacology study in which 12 adult subjects received rizatriptan, at total cumulative doses of 80 mg (given within four hours), two subjects experienced syncope and/or bradycardia. One subject, a female aged 29 years, developed vomiting, bradycardia, and dizziness beginning three hours after receiving a total of 80 mg rizatriptan (administered over two hours). A third degree AV block, responsive to atropine, was observed an hour after the onset of the other symptoms. The second subject, a 25 year old male, experienced transient dizziness, syncope, incontinence, and a five-second systolic pause (on ECG monitor) immediately after a painful venipuncture. The venipuncture occurred two hours after the subject had received a total of 80 mg rizatriptan (administered over four hours).

In addition, based on the pharmacology of rizatriptan, hypertension or other more serious cardiovascular symptoms could occur after overdosage. Gastro-intestinal decontamination (e.g., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with MAXALT. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.

The effects of haemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.

Shelf life: 3 years.

Do not store above 30°C.

All aluminium blister push through, packs of 2, 3, 6, 12 or 18 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.